Mri Safety Information; Directions For Use - Stryker Surpass Evolve Mode D'emploi

• Mass effect
• Myocardial infarction
• Neurological deficits
• Perforation or rupture of aneurysm
• Perforation of parent artery
• Progressive neurologic symptoms related to intracranial aneurysm (IA)
• Pseudoaneurysm formation
• Reaction to radiation exposure (i.e. alopecia, burns ranging in severity from
skin reddening to ulcers, cataracts, delayed neoplasia)
• Renal failure
• Retroperitoneal hematoma
• Seizure
• Stroke
• Subarachnoid hemorrhage
• Thromboembolism from device
• Thrombosis of parent artery or branch vessel
• Transient ischemic attack (TIA)
• Vasospasm
Risks that are eye related with the use of the Surpass Evolve™ Flow Diverter may
include:
• Amaurosis fugax/transient blindness
• Blindness
• Diplopia
• Reduced visual acuity/field
• Retinal artery occlusion
• Retinal ischemia
• Retinal infarction
• Vision impairment
Please notify your Stryker Neurovascular representative immediately if a device
malfunctions or patient complication or injury is experienced or suspected. Please
make every attempt to retain any suspect device, its associated components and
their packaging for return to Stryker Neurovascular.
MR

MrI saFetY InForMatIon

Non-clinical testing demonstrated that the Surpass Evolve Flow Diverter is MR
Conditional for single and overlapping up to 60mm in length.
A patient with the Surpass Evolve Flow Diverter can be scanned safely in an MR
system under the following conditions:
• Static magnetic field of 1.5 Tesla and 3 Tesla, only
• Maximum spatial gradient magnetic field of 3,000 Gauss/cm (30 T/m)
• Maximum MR system reported, whole body averaged specific absorption
rate (SAR) of 2 W/kg in the Normal Operating Mode
Under the scan conditions defined, the Surpass Evolve Flow Diverter is expected
to produce a maximum temperature rise of 3.0°C after 15 minutes of continuous
scanning (i.e., per pulse sequence). In non-clinical testing, the image artifact
caused by the Surpass Evolve Flow Diverter extends approximately 10mm from
this implant when imaged using a gradient echo pulse sequence and a 3 Tesla MR
system. The lumen cannot be visualized on gradient echo or T1-weighted, spin
echo pulse sequences.
Black (K) ∆E ≤5.0
Magnetic Resonance Conditional
Resonancia magnética, condicional
Résonance magnétique - Sous réserve
Magnetresonanz, bedingt
Risonanza magnetica – Con riserva
MRI-veilig onder bepaalde voorwaarden
Ressonância magnética - utilização
condicional
Magnetisk resonans - betinget
Για χρήση σε περιβάλλον αγνητικού
συντονισ ού υπό συνθήκη
Säker under vissa förhållanden vid
magnetisk resonans
MR-környezetben feltételesen
biztonságos
Magnetická rezonance – podmínečná
Rezonans magnetyczny – produkt
warunkowo bezpieczny
MR-sikker under visse betingelser
Manyetik Rezonans Uyumlu
MRI-ehdollinen
Uvjetno odobreno za magnetsku
rezonanciju
caution: The Surpass Evolve Flow Diverter may create local field inhomogeneity
and susceptibility artifacts during magnetic resonance angiography (MRA),
which may degrade the diagnostic quality to assess effective intracranial
aneurysm treatment.
The health state of the patient or the presence of other implants may require
reduction of the MRI limits.
How sUpplIeD
Stryker Neurovascular products are single use only, sterile and non-pyrogenic
in unopened packaging that is designed to maintain sterility unless the primary
product pouch has been opened or damaged.
warnInGs
• Do not use if sterile barrier or package is opened or damaged. If damage is
found, call your Stryker Neurovascular representative.
• Do not use if labeling is incomplete or illegible.
• Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization
may compromise the structural integrity of the device and/or lead to device
failure which, in turn, may result in patient injury, illness or death.
Handling and storage
Store in a cool, dry, dark place.
preparatIons For Use
surpass evolve Flow Diverter system selection
Appropriate selection of the device is important for patient safety. In order to
choose the optimal device for any given intracranial aneurysm neck length and
parent artery diameter, examine preprocedure angiograms.

DIrectIons For Use

Flow Diverter selection and preparation
1. Select an appropriate Surpass Evolve Flow Diverter System based on the
sizing recommendations in table 1.
table 1. Device sizes
Device Device length Unconstrained
Diameter (mm) Implant outer
(mm) Diameter (mm)
2.5 12, 13, 14, 15, 16,
17, 18, 19, 20
3.25 12, 13, 14, 15, 16,
17, 18, 19, 20, 21,
22, 25, 30
4.0 12, 13, 14, 15, 16,
17, 18, 19, 20, 21,
22, 25, 30, 40
4.5 12, 13, 14, 15, 16,
17, 18, 19, 20, 21,
22, 25, 30, 40
5.0 12, 13, 14, 15, 16,
17, 18, 19, 20, 21,
22, 25, 30, 40
4
recommended recommended
minimum vessel maximum vessel
diameter (mm) diameter (mm)
>2.5 ≥2.0 ≤2.5
>3.25 >2.5 ≤3.25
>4.0 >3.25 ≤4.0
>4.5 >4.0 ≤4.5
>5.0 >4.5 ≤5.0